Docetaxel in Treating Patients With Advanced Cancer of the Cervix

This study has been completed.

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00003445

First received: November 1, 1999

Last updated: June 25, 2013

Last verified: September 2001

History of Changes

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with advanced cancer of the cervix.

Condition	Intervention	Phase
Cervical Cancer	Drug: docetaxel	Phase 2


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Neoadjuvant Chemotherapy With Docetaxel in Advanced Cervical Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):


Study Start Date:	December 1997
Study Completion Date:	April 2004

Detailed Description:

OBJECTIVES: I. Assess the antitumor activity of docetaxel as neoadjuvant chemotherapy in patients with locally advanced squamous cell carcinoma of the cervix. II. Assess the tumor response, toxic effect, and survival rate of this regimen in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Treatment is repeated every 3 weeks for 3 courses. Patients are followed every 3 months posttreatment.

PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS: Histologically proven stage IIB, IIIA, IIIB, and IVA squamous cell carcinoma of the cervix Bidimensionally measurable disease No bilateral hydronefrosis

PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL Leukocytes at least 4,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) AST less than 1.25 times ULN Renal: BUN less than 30 mg/dL AND Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No prior or other concurrent malignancies, other than properly treated basal cell skin cancer

PRIOR CONCURRENT THERAPY: Not specified

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003445

Locations


Argentina
Unidad Oncologica Del Comahue
Neuquen, Argentina, 8300

Sponsors and Collaborators

Grupo Oncologico Cooperativo del Sur

Investigators


Study Chair:	Carlos Teodoro Vallejo, MD	Grupo Oncologico Cooperativo del Sur

More Information


ClinicalTrials.gov Identifier:	NCT00003445 History of Changes
Other Study ID Numbers:	GOCS-04-CC-97 CDR0000066473 NCI-V98-1456
Study First Received:	November 1, 1999
Last Updated:	June 25, 2013
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):


stage III cervical cancer stage IIB cervical cancer stage IVA cervical cancer cervical squamous cell carcinoma

Additional relevant MeSH terms:


Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases	Genital Diseases, Female Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016

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